NCT05961514

the Beijing Randomized Study Of Prostate Cancer Screening

The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30,000 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: Male
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

Summary

BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA \> 4ng/ml in initial screening.

Detailed description

The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population, which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers, and can reduce prostate cancer-specific mortality.This study will use a cluster randomized controlled trial method with a total of approximately 30,000 participants. The subjects will be randomly assigned to a control group (about 20,000 people) and a screening group (about 10,000 people), and some basic information will be obtained through a questionnaire survey. The screening group will undergo initial prostate-specific antigen (PSA) screening, and high-risk subjects (PSA \> 4ng/ml) will be randomly assigned to two groups. The standard biopsy group will undergo traditional systematic biopsy, while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Target biopsies	MRI/Fusion target biopsies combine magnetic resonance imaging (MRI) with ultrasound-guided biopsy techniques to obtain tissue samples from areas of the prostate gland that appear abnormal on MRI.
DIAGNOSTIC_TEST	systemic biopsies	transrectal ultrasound (TRUS) guided prostate systemic biopsies

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-27
• Last updated: 2023-11-02

Locations

1 site across 1 country: China